Production Pharmacist

2 weeks ago

Port Elizabeth, South Africa Aspen Pharma Group Full time
Job title : Production Pharmacist (Port Elizabeth) Job Location : Eastern Cape, Port Elizabeth Deadline : January 04, 2025 Quick Recommended Links
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Description

  • Monitor manufacturing compliance to GMP and statutory requirements
  • Monitor adherence to guidelines, procedures, and document controls
  • Deliver expected productivity targets as per business requirements
  • Related administrative tasks
  • Serve as back up to Team Leader on shift

Requirements
Planning and Procedures

  • Plan and prioritize daily, weekly, and monthly activities
  • Determine, request, and use resources/ assets optimally
  • Inspections and Verifications
  • Verify schedule 5 products
  • Verify certified clean status of rooms and equipment
  • Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials
  • Line & Production processing
  • Perform, review, and approve line sign on’s, closures and clearance authorizations
  • Perform, review, and approve batch reconciliations to product specifications and quality
  • Ensure production process adherence to standards and specifications
  • Process and system improvements
  • Manage, review, and approve change control programs and deviations/ concessions comply to standards and specifications
  • Manage and resolve customer complaints
  • Optimize processes and identify gaps in policies/ procedures
  • Drive CAPA investigations in area of focus
  • Compliance & Auditing
  • Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
  • Verify good document practice as per SOP and regulation
  • Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
  • Verify IPCs are in line with product quality and specifications
  • Review and approve preliminary batch records
  • Audit logbooks and systems
  • Troubleshooting
  • Investigate deviations and concessions, and assess risk
  • Raise deviations and implement corrective action
  • Raise maintenance notifications as and when required
  • Training and technical expertise
  • Train new Pharmacists and PMAs on SOPs in transition period
  • Identify refresher or awareness training needs
  • Administration & Record keeping
  • Complete batch records and labels
  • Complete deviation forms as required
  • Query documents and sign off declarations
  • Perform and verify calculations in BMR
  • Maintain and update records and systems as required
  • Retrieve supporting documentation and records to facilitate and support query resolution

Skills Required

Background/experience

  • Minimum of bachelor’s degree preferred, ideally in Pharmacy
  • 1-3 years’ related work experience
  • Pharmaceutical manufacturing experience
  • Registration with Pharmacy Council
  • Specific job skills
  • Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
  • Ability to interpret and implement policies, processes, and objectives

Competencies

  • Information gathering
  • Interrogating information
  • Meeting deadlines
  • Finalizing output
  • Taking action

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